Human-Centered AI for Compliance-First Manufacturing Excellence

About This Event

The pharmaceutical and biotechnology manufacturing landscape presents a striking contrast: while artificial intelligence (AI) adoption accelerates across industries, many life sciences companies face unique implementation challenges. Research shows the vast majority of life sciences manufacturers still rely on paper-based batch records, creating a fundamental disconnect—digitally mature companies generate extensive operational data that remains largely untapped, while paper-dependent operations struggle with critical insights trapped in physical records.

AI implementation in pharma manufacturing requires navigating complex regulatory requirements. Research with industry executives confirms successful AI adoption begins with process digitization of critical documentation like batch records. Manufacturers must build a compelling case for digital transformation through "Return on Automation" calculations that demonstrate tangible value beyond compliance.

This session offers actionable insights for implementing advanced digital solutions and AI in pharma manufacturing. We will explore specific examples—from AI systems that can predict batch deviations before they occur to solutions that reduce batch record review time by approximately 90%— all while maintaining human oversight in regulatory decisions. We'll also examine blue sky possibilities for fully integrated AI-enabled systems that have the potential to transform manufacturing workflows while ensuring compliance.

Whether your organization relies on paper batch records or has digitized operations, you'll gain strategies for balancing innovation with compliance, maintaining data integrity, and establishing governance that meets operational and regulatory needs with the goal of maximizing the business impact of AI in pharmaceutical manufacturing.

By attending this session, attendees will walk away with:

  • Tips for identifying high-value AI opportunities in pharma and biotech manufacturing, particularly around batch record management.
  • Recommendations for building a "Return on Automation" business case that justifies digitization investments.
  • Strategies for implementing "human-in-the-loop" AI systems that maintain regulatory compliance while delivering operational improvements.
  • Methods to keep sensitive manufacturing data secure while leveraging AI insights.
  • Opportunities to envision transformative applications of AI across production processes.

Matthew M. Lowe

Manufacturing, Quality, and Asset Management — Simplified with Life Sciences-Specialized AI.

Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now will continue his tenure as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl’s products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.

Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year post-market clinical study for orthopaedic devices.

Lowe has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.

Brian Curran

Senior VP of Strategic Growth

MasterControl

Brian Curran is Senior Vice President of Strategic Growth at MasterControl. Curran joined MasterControl in 2002 to direct and expand MasterControl's product development efforts. He has more than 25 years of experience leading the direction for enterprise and entrepreneurial software development companies. Curran began his career with IBM, where he spent five years leading consulting engagements with Fortune 500 companies such as MCI, BellSouth, and many others. After this, he held several director- and vice president-level product management and marketing positions for entrepreneurial software development companies in the telecommunications and web analytics sector. Curran has an MBA with an emphasis in information systems.

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